Lyophilisation Engineer
- Louth, Louth (IRL)
- Negotiable
- Permanent
- Start date: ASAP
- Ref: ACR
- manufacturing process + cgmp
- validation + calibration
- ehs training
- vaccines + pharmacy
- lyophilisation
Drug Product Lyophilization Specialist – Vaccines
Location: Louth, Ireland
Responsibilities:
⦁ Involvement in the manufacturing process design, construction of facility, co-leading C&Q, support on PQ, site operation, PEV, calibration activities.
⦁ Be responsible for the lyophilization production activities.
⦁ Plan and organize GMP/EHS training for group members.
⦁ Assign works to each member to fulfill the needs of production and equipment management.
⦁ Follow-up training and the qualities of operator, complete required skill trainings for each individual according to set training module.
⦁ Coordination and onsite support on preventative maintenance and repairing.
⦁ Coordination and onsite support on instrument
⦁ Participate in checking and arranging the document.
⦁ Be responsible for the management and assisting in the cleaning and maintenance including equipment in the area.
⦁ Be responsible for recovery and distribution.
⦁ Be responsible for executing 5S in the area.
⦁ Support validation in the area.
⦁ Participate in drafting and revising the document meeting cGMP.
⦁ Coordination and onsite support on instrument calibration.
⦁ Maintenance on equipment status labeling.
⦁ Be responsible for the shipping and locating of facilities and equipment in the area.
⦁ Introduction new facilities.
⦁ Change control compiling and implementation.
⦁ Deviation investigation.
⦁ Department fixed assets management.
⦁ Prompt repair machine breakdown.
⦁ Continuously improve the performance department facilities.
⦁ Ensure data integrity of all facilities.
Have you?
⦁ Degree or above, major in biology, pharmacy, chemistry or engineering,
⦁ In depth technical knowledge and experience in biopharmaceutical development, GMP manufacturing, and quality assurance and control.
⦁ At least 10 years experiences in Vaccine, Biotech or pharmaceutical industry.
⦁ Demonstrated excellent management skills and leadership.
⦁ Global perspective, Strategic thinking, Strong leadership.
⦁ Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
⦁ Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
